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Objectives: This study sought to evaluate inter-core lab variability in quantitative coronary angiography (QCA) analysis of bifurcation lesions., Background: QCA of bifurcation lesions is challenging. To date there are no data available on the inter-core lab variability of bifurcation QCA analysis., Methods: The randomized Tryton IDE (Tryton Pivotal IDE Coronary Bifurcation Trial) compared the Tryton Side Branch Stent (Tryton Medical, Durham, North Carolina) with balloon angioplasty as side branch treatment. QCA was performed in an angiographic subcohort (n = 326) at 9-month follow-up. Inter-core lab variability of QCA analysis between the Cardiovascular Research Foundation and the Cardialysis core labs was evaluated before and after alignment of the used QCA methodology using angiographic data derived from this angiographic follow-up cohort., Results: In the original analysis, before alignment of QCA methodology, the mean difference between the core labs (bias) was large for all QCA parameters with wide 95% limits of agreement (1.96 × SD of the bias), indicating marked variability. The bias of the key angiographic endpoint of the Tryton trial, in-segment percentage diameter stenosis (%DS) of the side branch, was 5.5% (95% limits of agreement: -26.7% to 37.8%). After reanalysis, the bias of the in-segment %DS of the side branch reduced to 1.8% (95% limits of agreement: -16.7% to 20.4%). Importantly, after alignment of the 2 core labs, there was no longer a difference between both treatment groups (%DS of the side branch: treatment group A vs. group B: 34.4 ± 19.4% vs. 32.4 ± 16.1%, p = 0.340)., Conclusions: Originally, a marked inter-core lab variability of bifurcation QCA analysis was found. After alignment of methodology, inter-core lab variability decreased considerably and impacted angiographic trial results. This latter finding emphasizes the importance of using the same methodology among different core labs worldwide. (Tryton Pivotal Prospective, Single Blind, Randomized Controlled Study to Evaluate the Safety & Effectiveness of the Tryton Side Branch Stent Used With DES in Treatment of de Novo Bifurcation Lesions in the Main Branch & Side Branch in Native Coronaries [TRYTON]; NCT01258972)., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to investigate the impact of left main coronary artery (LMCA) 3-dimensional (3D) bifurcation angle (BA) parameters on 5-year clinical outcomes of patients randomized to LMCA percutaneous coronary intervention (PCI) in the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) trial., Background: BA can affect outcome after bifurcation PCI; 3D angiographic analysis provides reliable BA measurements., Methods: The diastolic distal BA (between left anterior descending and left circumflex) and its systolic-diastolic range were explored. A stratified post-hoc survival analysis was performed for 5-year major adverse cardiac and cardiovascular events (MACCE) (all-cause death, cerebrovascular accident, myocardial infarction, or repeat revascularization), a safety endpoint (all-cause death, cerebrovascular accident, or myocardial infarction), and repeat revascularization. Analysis was performed in patients where 3D BA was available pre- and post-PCI., Results: Of 266 patients eligible for analysis, 185 underwent bifurcation PCI (group B); 1 stent was used in 75 patients (group B1), whereas ≥2 stents were used in 110 patients (group B2). Stratification across pre-PCI diastolic distal BA tertiles (<82°, 82° to 106°, ≥107°) failed to show any difference in MACCE rates either in the entire study population (p = 0.99) or in group B patients (p = 0.78). Group B patients with post-PCI systolic-diastolic range <10° had significantly higher MACCE rates (50.8% vs. 22.7%, p < 0.001); repeat revascularization and safety endpoint rates were also higher (37.4% vs. 15.5%, p = 0.002, and 25.4% vs. 14.1%, p=0.055, respectively). Post-PCI systolic-diastolic range <10° was an independent predictor of MACCE (hazard ratio: 2.65; 95% confidence interval: 1.55 to 4.52; p < 0.001) in group B patients., Conclusions: A restricted post-procedural systolic-diastolic distal BA range resulted in higher 5-year adverse event rates after LMCA bifurcation PCI. Pre-PCI BA value did not affect the clinical outcome., (Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to assess the additional value of the Global Risk--a combination of the SYNTAX Score (SXscore) and additive EuroSCORE--in the identification of a low-risk population, who could safely and efficaciously be treated with coronary artery bypass graft surgery (CABG) or percutaneous coronary intervention (PCI)., Background: PCI is increasingly acceptable in appropriately selected patients with left main stem or 3-vessel coronary artery disease., Methods: Within the SYNTAX Trial (Synergy between PCI with TAXUS and Cardiac Surgery Trial), all-cause death and major adverse cardiac and cerebrovascular events (MACCE) were analyzed at 36 months in low (GRC(LOW)) to high Global Risk groups, with Kaplan-Meier, log-rank, and Cox regression analyses., Results: Within the randomized left main stem population (n = 701), comparisons between GRC(LOW) groups demonstrated a significantly lower mortality with PCI compared with CABG (CABG: 7.5%, PCI: 1.2%, hazard ratio [HR]: 0.16, 95% confidence interval [CI]: 0.03 to 0.70, p = 0.0054) and a trend toward reduced MACCE (CABG: 23.1%, PCI: 15.8%, HR: 0.64, 95% CI: 0.39 to 1.07, p = 0.088). Similar analyses within the randomized 3-vessel disease population (n = 1,088) demonstrated no statistically significant differences in mortality (CABG: 5.2%, PCI: 5.8%, HR: 1.14, 95% CI: 0.57 to 2.30, p = 0.71) or MACCE (CABG: 19.0%, PCI: 24.7%, HR: 1.35, 95% CI: 0.95 to 1.92, p = 0.10). Risk-model performance and reclassification analyses demonstrated that the EuroSCORE-with the added incremental benefit of the SXscore to form the Global Risk-enhanced the risk stratification of all PCI patients., Conclusions: In comparison with the SXscore, the Global Risk, with a simple treatment algorithm, substantially enhances the identification of low-risk patients who could safely and efficaciously be treated with CABG or PCI., (Copyright © 2012 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study sought to assess the impact of the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score (SXscore) on clinical outcomes in patients undergoing percutaneous coronary intervention., Background: The SXscore has been demonstrated to have an ability to predict clinical outcomes in patients undergoing percutaneous revascularization. Current studies are limited by the relatively small number of patients in each SXscore group., Methods: Patient-level data from 7 contemporary coronary stent trials were pooled by an independent academic research organization (Cardialysis, Rotterdam, the Netherlands). Analysis was performed on a cohort of 6,508 patients treated with drug-eluting stents and who had calculated SXscores. Clinical outcomes in terms of death, myocardial infarction (MI), repeat revascularization, and major adverse cardiac events (MACE, a composite of death, MI, and repeat revascularization) were subsequently stratified according to SXscore quartiles: SXscore(Q1) ≤ 8 (n = 1,702); 8 < SXscore(Q2) < 15 (n = 1,528); 15 ≤ SXscore(Q3) < 23 (n = 1,620); and SXscore(Q4) ≥ 23 (n = 1,658)., Results: One-year outcomes were available in 6,496 patients (99.8%). At 1-year follow-up, all clinical outcomes including mortality, MI, repeat revascularization, MACE, and definite and any stent thrombosis were all significantly higher in patients in the highest SXscore quartile. Similar trends were observed in a subgroup of 2,093 patients (32.2%) who presented with an ST- or non-ST-segment elevation MI. The rate of MACE among patients with an SXscore > 32 and ≤ 32 was 24.9% and 14.0%, respectively (p < 0.001). The SXscore was identified as an independent predictor of all clinical outcomes including mortality, MACE, and stent thrombosis (p < 0.001 for all)., Conclusions: This study confirms the consistent ability of the SXscore to identify patients who are at highest risk of adverse events., (Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: We investigated the long-term clinical outcomes and independent predictors of major cardiac events in unprotected left main coronary artery disease (ULMCA) patients treated by percutaneous coronary intervention with drug-eluting stent (DES)., Background: There is limited information on long-term (>3 years) outcomes after DES implantation for ULMCA. Furthermore, bifurcation angle and SYNTAX (Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery) score are emerging as parameters for patient risk stratification, and their prognostic implications have still to be elucidated., Methods: One hundred forty-eight patients with ULMCA treated with DES were analyzed and compared with a historical cohort of 79 patients who received bare-metal stents for the treatment of ULMCA. Patient-oriented composite end point was defined as the occurrence of all-cause death, any myocardial infarction, or any revascularization., Results: The 4-year cumulative incidence of all-cause death, any myocardial infarction, any revascularization, and patient-oriented composite were 35.6%, 3.8%, 25.2%, and 54.4%, respectively. These end points had relatively increased from 1 year to 4 years by Delta70%, Delta5%, Delta50%, and Delta68%, respectively. When compared with a historical cohort who received bare-metal stents for ULMCA treatment, landmark analysis performed after the first 2 years of follow-up demonstrated that the DES cohort had significantly higher patient-oriented composite end point over the last 2 years of follow-up (26% vs. 8%, p = 0.02). EuroSCORE (European System for Cardiac Operative Risk Evaluation), cardiogenic shock, and SYNTAX score were identified as independent predictors for the 4-year patient-oriented composite, whereas bifurcation angle was not., Conclusions: Late increase in patient-oriented composite end points after DES implantation for ULMCA warrants careful and long-term follow-up. SYNTAX score and EuroSCORE appear to have a significant prognostic value in long-term patient risk., (Copyright 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: We explore the bifurcation angle (BA) parameters of the left main coronary artery (LM), the effect of percutaneous coronary intervention (PCI) on this angulation, and the impact of BA on clinical outcome., Background: The BA is emerging as a predictor of outcome after PCI of bifurcation lesions. Three-dimensional (3D) quantitative coronary angiography (QCA) overcomes the shortcomings of 2-dimensional analysis and provides reliable data., Methods: This is a substudy of the SYNTAX (SYNergy Between Percutaneous Coronary Intervention With TAXus and Cardiac Surgery) trial. The cineangiograms of the 354 patients who underwent PCI of their LM stem were analyzed with 3D QCA software (CardiOp-B, Paieon Medical, Ltd., Rosh Ha'ayin, Israel). The proximal BA (between LM and left circumflex [LCX]) and the distal BA (between left anterior descending and LCX) were computed in end-diastole and end-systole, both before and after PCI. The cumulative major adverse cardiac and cardiovascular event (MACCE) rates throughout the 12-month period after randomization were stratified across pre-PCI distal BA values and compared accordingly., Results: Complete analysis was feasible in 266 (75.1%) patients. Proximal and distal BA had mean pre-PCI end-diastolic values of 105.9 +/- 21.7 degrees and 95.6 +/- 23.6 degrees , respectively, and were inversely correlated (r = -0.75, p < 0.001). During systolic motion of the heart there was an enlargement of the proximal angle and a reduction of the distal angle (DeltaBA -8.2 degrees and 8.5 degrees , respectively, p < 0.001 for both). The PCI resulted in a mean decrease in the distal BA (DeltaBA 4.5 degrees , p < 0.001). The MACCE rates did not differ across distal BA values; freedom from MACCE at 12 months was 82.8%, 85.4%, and 81.1% (p = 0.74) for diastolic values (first through third tertile)., Conclusions: Left main BA analysis with 3D QCA is feasible. Both proximal and distal angles are affected by cardiac motion; PCI modifies the distal angle. There is no clear difference in event rates across pre-PCI distal BA values., (Copyright (c) 2010 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)